Страна: Канада
мова: англійська
Джерело: Health Canada
DEXTROSE; POTASSIUM CHLORIDE
BAXTER CORPORATION
B05BB02
ELECTROLYTES WITH CARBOHYDRATES
5G; 300MG
SOLUTION
DEXTROSE 5G; POTASSIUM CHLORIDE 300MG
INTRAVENOUS
1000ML
Ethical
REPLACEMENT PREPARATIONS
Active ingredient group (AIG) number: 0200305003; AHFS:
APPROVED
2012-12-07
1 of 14 PRESCRIBING INFORMATION POTASSIUM CHLORIDE IN 5% DEXTROSE INJECTION, USP IN VIAFLEX PLASTIC CONTAINER IV Fluid and Nutrient Replenisher Baxter Corporation Mississauga, Ontario L5N 0C2 Canada Date of Revision: March 11, 2021 Submission Control No: 249296 Baxter, Viaflex and PL 146 are registered trademarks of Baxter International Inc. 2 of 14 POTASSIUM CHLORIDE IN 5% DEXTROSE INJECTION, USP IN VIAFLEX PLASTIC CONTAINER SUMMARY PRODUCT INFORMATION Potassium Chloride in 5% Dextrose Injection, USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment and caloric supply in a single dose container for intravenous administration. It contains no antimicrobial agents. Composition, osmolarity, pH, ionic concentration and caloric content are shown in TABLE 1. TABLE 1. Size Composition (g/l) Osmolarity Ionic Concentration How Supplied Potassium Chloride in 5% Dextrose Injection, USP mL Dextrose Hydrous, USP* Potassium Chloride, USP (KCl) mOsmol/L pH Potassium Chloride Caloric Conct. (kcal/L) 20 mmol/L 1000 50 1.5 292 4.0 20 20 170 40 mmol/L 1000 50 3 332 4.0 40 40 170 *The dextrose is purified from corn and may contain fructose. The VIAFLEX plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). Water in a solution in the container can permeate through the plastic wall, but in an insufficient amount to significantly affect the solution. Before the product expires, a very small amounts of chemical components of the plastic can be leached into the solution in the container, such as up to 5 parts per million for DEHP. No safety issues of the plastic material were identified in USP biological tests in animals as well as by tissue culture toxicity studies. ACTIONS Potassium Chloride in 5% Dextrose Injection, USP has value as a source of water, electrolytes and calories. It is capable of inducing diuresis depending on the clinical condition of the patient. INDICATIONS AND CLINICAL USE Potassium Chloride in 5% Dextrose Injection, USP is indicated as a source of Прочитайте повний документ